QUETIAPINE FUMARATE | N020639 | CHEPLAPHARM ARZNEIMITTEL GMBH
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Pharmobedient Consulting, LLC FDA-2025-P-1033 · 8 docket documents Pharmobedient Consulting, LLC submitted a suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Quetiapine Tablets 12.5 mg suitable for submission in an Abbreviated New Drug Application, with SEROQUEL | Suitability | 2025-04-03 | Open | Pharmobedient Consulting, LLC |
Covington & Burling LLP (AstraZeneca Pharmaceuticals LP) - Citizen Petition FDA-2011-P-0662 · 3 docket documents AstraZeneca Pharmaceuticals LP, the NDA holder for SEROQUEL (quetiapine fumarate), filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA not approve any quetiapine ANDA if the proposed labeling omits information that FDA required AstraZe | 505(q) | 2011-09-20 | Denied | — |
Lachman Consultant Services, Inc - Citizen Petition FDA-2007-P-0011 · 6 docket documents Lachman Consultant Services, Inc. filed this citizen petition requesting that the FDA determine whether AstraZeneca Pharmaceuticals LP voluntarily withdrew Seroquel (quetiapine fumarate) 150 mg tablets, approved under NDA 20-639, for safety or effectiveness reasons, or whether the discontinuation wa | 505(q) | 2008-04-10 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$18.71
per ea
Lowest NADAC/Unit
$6.38
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00310027910SEROQUEL 400 MG TABLET | $18.71 | EA | Brand | $0.1662 | 2026-06-17 |
| 00310027210SEROQUEL 200 MG TABLET | $11.99 | EA | Brand | $0.0866 | 2026-06-17 |
| 00310027110SEROQUEL 100 MG TABLET | $6.38 | EA | Brand | $0.0512 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.